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临床试验/NCT05002114
NCT05002114撤回1 期

Evaluation of a Specific Transdermal Cannabidiol Product for Chronic Musculoskeletal Joint Pain.

Louisiana State University Health Sciences Center Shreveport0 个研究点开始时间: 2023年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
撤回
发起方
主要终点
Change in PGI-S

研究概览

简要总结

Double-blind, randomized into two arms (TC and TP): patients get either topical cannabidiol or topical placebo up to three times daily. Inclusion criteria will be chronic joint pain with intent to treat or currently treated with opioids. Exclusion criteria will include current cannabis use, severe medical illness or lacking in capacity to be involved in study. TC and TP will be prescribed for use TID in predefined dosages and quantities.

详细描述

Introduction and Rationale

Currently, the opioid epidemic is a public health crisis. Use of opioids for chronic pain are a large component of this crisis. If alternative means can be developed to treat chronic pain that can replace the use of opioid-based treatments, this can improve clinical outcomes and quality of life.

Arthritis and musculoskeletal pain are often chronic conditions that cause significant morbidity. Historically, one study estimated that the lifetime incidence is as high as 47% for osteoarthritis over the lifespan, increasing with age and also increasing to 60% with a body mass index over than 30. In our society today with over 50% of the population suffering from obesity, this is a significant problem.

While cannabis products have been referenced for treating numerous medical issues including a number of pain-related conditions, it has only been recently that mechanisms outside the central nervous system have been recognized. There is very little published in regards to the use of cannabidiol (CBD) in the treatment of arthritic pain, and even less on the topical application of CBD products in its use in this manner. Two previous studies demonstrated the efficacy of a local/transdermal application of CBD in rodent models of arthritis. Activity at the TRPV2 receptor is one possible mechanism for this putative mechanism. Another possible interaction is at the GPR55 receptor.

The earliest known references to the medicinal properties of cannabis can be found in the "Shennong Ben Cao Jing", which describe Chinese uses of herbal remedies from as early as 2700 BC. In later compilations of this work, cannabis is described as being utilized for the treatment of pain and inflammation. Since that time, cannabis has been used world-wide both medicinally and for recreational purposes. It has only been a recent development (within the past 100 years) that public health regulations have prohibited the use of cannabis products.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

盲法说明

double-blind, randomized, placebo-controlled.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Placebo Group

Placebo Comparator

Does not get active topical CBD. Instead, gets an identical placebo-containing topical agent.

干预措施: Placebo (Other)

Active Group

Experimental

Does get active topic CBD.

干预措施: Cannabidiol (Drug)

结局指标

主要结局

Change in PGI-S

时间窗: Two time points, before treatment and after 4 weeks.

Patient Global Impression of Severity Scale from 1 to 7 with higher scores indicating worse condition

Change in PGI-C

时间窗: Two time points, before treatment and after 4 weeks.

Patient Global Impression of Change Scale from 1 to 7 with higher scores indicating worse condition

Change in QOLS

时间窗: Two time points, before treatment and after 4 weeks.

Quality of Life Scale Scale from 16 to 112, with higher scores indicating better condition

次要结局

未报告次要终点

研究者

发起方
Louisiana State University Health Sciences Center Shreveport
申办方类型
Other
责任方
Principal Investigator
主要研究者

James C. Patterson, II, MD. Ph

Clinical Director, Louisiana Addiction Research Center

Louisiana State University Health Sciences Center Shreveport

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